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School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents

Primary Purpose

Obesity, Cardiovascular Health, Diabetes Mellitus

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Long-term educational program
Short-term educational program
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Cardiovascular Health, Diabetes, Adolescents, Physical Activity, Diet, School-Based

Eligibility Criteria

11 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools.

Exclusion Criteria:

  • No exclusion criteria.

Sites / Locations

  • School of Pharmacy. University of Barcelona.
  • Fundación SHE
  • Centro Nacional de Investigaciones Cardiovasculares Carlos III

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Short Intervention

Long Intervention

Arm Description

The usual educational program is applied

A two-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.

A four-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.

Outcomes

Primary Outcome Measures

Changes in the composite ICH score of adolescents from baseline to year 2 and 4
The ICH score measures cardiovascular health and includes 7 components: - Behaviors factors: No smoking Being physically active Good nutritional habits Normal weight - Health factors: Normal blood pressure Normal cholesterol level Normal glucose levels To meet the complete definition of ideal cardiovascular health, an individual would need to meet the ideal levels of all 7 components.

Secondary Outcome Measures

Changes in body mass index from baseline to year 2 and 4
Change in body mass index (kg/m^2), calculated after measure weight (kg) and height (meter).
Changes in waist circumference from baseline to year 2 and 4
Change in waist circumference (cm) measured in triplicate
Changes in percentage of body fat from baseline to year 2 and 4
Change in total adiposity measured by bioelectrical impedance (percentage of fat).
Changes in distribution of body fat from baseline to year 2 and 4
Change in adiposity distribution measured by dual energy X-ray absorptiometry, that calculate total body fat, regional fat, including android, gynoid, visceral and lean mass.
Changes in dietary habits from baseline to year 2 and 4
To evaluate the association between food and nutrient intake and changes in adiposity parameters. To assess changes in diet and adherence to the Mediterranean diet a validated Food Frequency Questionnaire (FFQ) (Tresserra-Rimbau et al., 2013) will be used. A shorter FFQ (Children's Eating Habits Questionnaire - Food Frequency Questionnaire (CEHQ-FFQ) (Lanfer et al., 2011; Bel-Serrat et al. 2014)) will also be used to analyze dietary patterns.
Changes in attitudes about eating from baseline to year 2 and 4 [ Time Frame: 2 and 4 years
To evaluate the relationship between changes in attitudes and changes in adiposity parameters. A validated questionnaire will be used to assess attitudes about eating (Lima-Serrano et al., 2012).
Changes in polyphenol consumption from baseline to year 2 and 4
Dietary polyphenol (PP) intake will be estimated from FFQ and data from the PP content in foods, obtained from the Phenol-explorer data base. With this methodology, it can obtain an estimation of total PP intake by each individual and different PP classes. For the determination of phenolics and their metabolites in human urine, will be used solid-phase extraction and ultra-HPLC coupled to mass spectrometry (Martinez-Huelamo et al., 2015).
Changes in carotenoids consumption from baseline to year 2 and 4
Carotenoids and retinol consumption will be also estimated from the longer FFQ. Total energy and micronutrient intake will be obtained using the Food Processor Nutrition and Fitness Software (ESHA Research, Salem, OR).
Changes in energy and nutrients consumption from baseline to year 2 and 4
Total energy and micronutrient intake will be obtained from a validated Food Frequency Questionnaire (Tresserra-Rimbau et al., 2013) using the Food Processor Nutrition and Fitness Software.
Changes in metabolomics from baseline to year 2 and 4
To evaluate the effect of the intervention on metabolism through a metabolomic approach. Urine and salivary samples will be collected to perform a metabolomics analysis in order to evaluate metabolic changes due to educational intervention on dietary and physical activity habits. Liquid chromatography coupled to quadrupole time of-flight mass spectrometry (HPLC-q-TOF) will be used for such analysis which is able to measure thousands of metabolites simultaneously from only minimal amounts of sample. Data mining analysis will be performed using XCMS-R package. The preprocessed data obtained by XCMS in negative and positive ionization will be separately exported to SIMCA 13.0.3 software (Umetrics) to perform unsupervised and supervised multivariate analysis to detect metabolic changes among groups.
Changes in physical activity from baseline to year 2 and 4
To study the association between changes in physical activity and changes in adiposity parameters . Actigraph wGT3X-BT accelerometers that allow the registration of the amount and intensity of physical activity will be used during 7 days per evaluation time-point. To complete this information a diary with questions about the type of physical activity performed during the 7 days will be collected. A validated questionnaire will be also used to assess physical activity habits (Barbosa et al., 2007).
Changes in sedentary habits from baseline to year 2 and 4
To study the association between changes in sedentary habits and changes in adiposity parameters. Information on sedentary time from Actigraph wGT3X-BT accelerometers will be taken into account. In addition, we will measure sedentary leisure time spent with the computer/console/TV /mobile (ENSE 2012).
Changes in attitudes towards abuse substances from baseline to year 2 and 4
The attitudes towards abuse substances will be assessed by a validated questionnaire (Lima-Serrano et al., 2013). An additional questionnaire will be used to assess self-efficacy (Markham et al., 2009).
Changes in smoking habits from baseline to year 2 and 4
Validated questionnaires will be used to assess smoking status itself, and in its immediate environment (Moreno et al., 2012 Lana, 2010).
Changes in perception of the self-image from baseline to year 2 and 4
A questionnaire to assess the perception of the self-image will be used to obtain a pattern of individual acceptance with his/her figure (Stunkard et al., 1990).
Changes in self-esteem from baseline to year 2 and 4
Self-esteem will be assessed using validated questionnaire (Rajmil et al., 2003).
Changes in emotional eating from baseline to year 2 and 4
Emotional eating will be assessed using validated questionnaire (Jauregui-Lobera et al., 2014)
Changes in mood from baseline to year 2 and 4
Self-efficacy will be assessed using a validated questionnaire (Vázquez Fernández et al., 2013).
Evaluation of the shorter vs. longer educational intervention effectiveness by comparison of 2 and 4 year results on all outcomes
The effectiveness of a shorter vs. longer educational intervention program (2 and 4 year) will be assessed by comparison of final (4 year) results on all proposed outcomes.
Cardiovascular score validation
The BEWAT score, which includes the assessment of Blood pressure, Exercise, Weight, Alimentation (fruit and vegetables) and Tobacco consumption, will be also derived. This simple and non-invasive score (score from 0 to 15 points) will be validated against the ICH score, and will serve for future studies in adolescents.
Changes in the composite ICH score of adolescents from baseline to adulthood

Full Information

First Posted
January 9, 2018
Last Updated
November 2, 2022
Sponsor
University of Barcelona
Collaborators
SHE Foundation, Centro Nacional de Investigaciones Cardiovasculares Carlos III, Fundació La Marató de TV3, Obra social La Caixa
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1. Study Identification

Unique Protocol Identification Number
NCT03504059
Brief Title
School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents
Official Title
School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Barcelona
Collaborators
SHE Foundation, Centro Nacional de Investigaciones Cardiovasculares Carlos III, Fundació La Marató de TV3, Obra social La Caixa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background and objective: There is an alarming increase in obesity and unhealthy lifestyles in adolescents. This issue threatens to have a highly negative health and socioeconomic impact in the near future. The only way to tackle this epidemic is to implement effective preventive strategies able to positively impact on youth lifestyle behaviours. The school is the most appropriate environment for such an intervention. The main objective of this study is to evaluate the efficacy of a comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles. The project consortium constitutes a unique framework of research groups at the forefront of novel and successful approaches aiming to healthier behaviours and dietary habits. Methodology: A cluster-randomized controlled trial involving 24 secondary schools in Spain will be carried out. Schools will be 1:1:1 randomized to receive a short-term (2-year) or a long-term (4-year) comprehensive educational program, or to receive the usual curriculum (control). Participants will be evaluated at baseline, and after 2 and 4 years with the following: weight scale, circumference measuring tape, bioelectrical impedance, dual energy X-ray absorptiometry, sphygmomanometer, blood analysis, saliva and urine analysis, accelerometers, and questionnaires. The primary outcome is the change in obesity and other health parameters from baseline to year 2 and 4, as assessed by the Ideal Cardiovascular Health score. Secondary outcomes include the change in adiposity, anthropometry and body composition parameters, physical activity and dietary habits, polyphenol and carotenoid intake, metabolomics and attitudes. Participants will be measured again when they reach 20 years old. Expected results: The investigators expects to show that a school-based educational intervention induces favorable lifestyle changes and improves cardiovascular health among Spanish adolescents, including obesity/adiposity and metabolic profiles. If successful, this strategy could be widely adopted having a meaningful effect on obesity and cardiovascular health promotion. Additionally, associations between health parameters and bioactive dietary compounds intake and metabolic profiles will be stablished.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Health, Diabetes Mellitus
Keywords
Obesity, Cardiovascular Health, Diabetes, Adolescents, Physical Activity, Diet, School-Based

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The usual educational program is applied
Arm Title
Short Intervention
Arm Type
Active Comparator
Arm Description
A two-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.
Arm Title
Long Intervention
Arm Type
Active Comparator
Arm Description
A four-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.
Intervention Type
Behavioral
Intervention Name(s)
Long-term educational program
Intervention Description
Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.
Intervention Type
Behavioral
Intervention Name(s)
Short-term educational program
Intervention Description
Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.
Primary Outcome Measure Information:
Title
Changes in the composite ICH score of adolescents from baseline to year 2 and 4
Description
The ICH score measures cardiovascular health and includes 7 components: - Behaviors factors: No smoking Being physically active Good nutritional habits Normal weight - Health factors: Normal blood pressure Normal cholesterol level Normal glucose levels To meet the complete definition of ideal cardiovascular health, an individual would need to meet the ideal levels of all 7 components.
Time Frame
2 and 4 years
Secondary Outcome Measure Information:
Title
Changes in body mass index from baseline to year 2 and 4
Description
Change in body mass index (kg/m^2), calculated after measure weight (kg) and height (meter).
Time Frame
2 and 4 years
Title
Changes in waist circumference from baseline to year 2 and 4
Description
Change in waist circumference (cm) measured in triplicate
Time Frame
2 and 4 years
Title
Changes in percentage of body fat from baseline to year 2 and 4
Description
Change in total adiposity measured by bioelectrical impedance (percentage of fat).
Time Frame
2 and 4 years
Title
Changes in distribution of body fat from baseline to year 2 and 4
Description
Change in adiposity distribution measured by dual energy X-ray absorptiometry, that calculate total body fat, regional fat, including android, gynoid, visceral and lean mass.
Time Frame
2 and 4 years
Title
Changes in dietary habits from baseline to year 2 and 4
Description
To evaluate the association between food and nutrient intake and changes in adiposity parameters. To assess changes in diet and adherence to the Mediterranean diet a validated Food Frequency Questionnaire (FFQ) (Tresserra-Rimbau et al., 2013) will be used. A shorter FFQ (Children's Eating Habits Questionnaire - Food Frequency Questionnaire (CEHQ-FFQ) (Lanfer et al., 2011; Bel-Serrat et al. 2014)) will also be used to analyze dietary patterns.
Time Frame
2 and 4 years
Title
Changes in attitudes about eating from baseline to year 2 and 4 [ Time Frame: 2 and 4 years
Description
To evaluate the relationship between changes in attitudes and changes in adiposity parameters. A validated questionnaire will be used to assess attitudes about eating (Lima-Serrano et al., 2012).
Time Frame
2 and 4 years
Title
Changes in polyphenol consumption from baseline to year 2 and 4
Description
Dietary polyphenol (PP) intake will be estimated from FFQ and data from the PP content in foods, obtained from the Phenol-explorer data base. With this methodology, it can obtain an estimation of total PP intake by each individual and different PP classes. For the determination of phenolics and their metabolites in human urine, will be used solid-phase extraction and ultra-HPLC coupled to mass spectrometry (Martinez-Huelamo et al., 2015).
Time Frame
2 and 4 years
Title
Changes in carotenoids consumption from baseline to year 2 and 4
Description
Carotenoids and retinol consumption will be also estimated from the longer FFQ. Total energy and micronutrient intake will be obtained using the Food Processor Nutrition and Fitness Software (ESHA Research, Salem, OR).
Time Frame
2 and 4 years
Title
Changes in energy and nutrients consumption from baseline to year 2 and 4
Description
Total energy and micronutrient intake will be obtained from a validated Food Frequency Questionnaire (Tresserra-Rimbau et al., 2013) using the Food Processor Nutrition and Fitness Software.
Time Frame
2 and 4 years
Title
Changes in metabolomics from baseline to year 2 and 4
Description
To evaluate the effect of the intervention on metabolism through a metabolomic approach. Urine and salivary samples will be collected to perform a metabolomics analysis in order to evaluate metabolic changes due to educational intervention on dietary and physical activity habits. Liquid chromatography coupled to quadrupole time of-flight mass spectrometry (HPLC-q-TOF) will be used for such analysis which is able to measure thousands of metabolites simultaneously from only minimal amounts of sample. Data mining analysis will be performed using XCMS-R package. The preprocessed data obtained by XCMS in negative and positive ionization will be separately exported to SIMCA 13.0.3 software (Umetrics) to perform unsupervised and supervised multivariate analysis to detect metabolic changes among groups.
Time Frame
2 and 4 years
Title
Changes in physical activity from baseline to year 2 and 4
Description
To study the association between changes in physical activity and changes in adiposity parameters . Actigraph wGT3X-BT accelerometers that allow the registration of the amount and intensity of physical activity will be used during 7 days per evaluation time-point. To complete this information a diary with questions about the type of physical activity performed during the 7 days will be collected. A validated questionnaire will be also used to assess physical activity habits (Barbosa et al., 2007).
Time Frame
2 and 4 years
Title
Changes in sedentary habits from baseline to year 2 and 4
Description
To study the association between changes in sedentary habits and changes in adiposity parameters. Information on sedentary time from Actigraph wGT3X-BT accelerometers will be taken into account. In addition, we will measure sedentary leisure time spent with the computer/console/TV /mobile (ENSE 2012).
Time Frame
2 and 4 years
Title
Changes in attitudes towards abuse substances from baseline to year 2 and 4
Description
The attitudes towards abuse substances will be assessed by a validated questionnaire (Lima-Serrano et al., 2013). An additional questionnaire will be used to assess self-efficacy (Markham et al., 2009).
Time Frame
2 and 4 years
Title
Changes in smoking habits from baseline to year 2 and 4
Description
Validated questionnaires will be used to assess smoking status itself, and in its immediate environment (Moreno et al., 2012 Lana, 2010).
Time Frame
2 and 4 years
Title
Changes in perception of the self-image from baseline to year 2 and 4
Description
A questionnaire to assess the perception of the self-image will be used to obtain a pattern of individual acceptance with his/her figure (Stunkard et al., 1990).
Time Frame
2 and 4 years
Title
Changes in self-esteem from baseline to year 2 and 4
Description
Self-esteem will be assessed using validated questionnaire (Rajmil et al., 2003).
Time Frame
2 and 4 years
Title
Changes in emotional eating from baseline to year 2 and 4
Description
Emotional eating will be assessed using validated questionnaire (Jauregui-Lobera et al., 2014)
Time Frame
2 and 4 years
Title
Changes in mood from baseline to year 2 and 4
Description
Self-efficacy will be assessed using a validated questionnaire (Vázquez Fernández et al., 2013).
Time Frame
2 and 4 years
Title
Evaluation of the shorter vs. longer educational intervention effectiveness by comparison of 2 and 4 year results on all outcomes
Description
The effectiveness of a shorter vs. longer educational intervention program (2 and 4 year) will be assessed by comparison of final (4 year) results on all proposed outcomes.
Time Frame
4 years
Title
Cardiovascular score validation
Description
The BEWAT score, which includes the assessment of Blood pressure, Exercise, Weight, Alimentation (fruit and vegetables) and Tobacco consumption, will be also derived. This simple and non-invasive score (score from 0 to 15 points) will be validated against the ICH score, and will serve for future studies in adolescents.
Time Frame
4 years
Title
Changes in the composite ICH score of adolescents from baseline to adulthood
Time Frame
8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools. Exclusion Criteria: No exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa M Lamuela-Raventós, PhD
Organizational Affiliation
University of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gloria Santos-Beneit, PhD
Organizational Affiliation
SHE Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan M Fernández Alvira, PhD
Organizational Affiliation
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valentín Fuster, PhD, MD
Organizational Affiliation
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Pharmacy. University of Barcelona.
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Fundación SHE
City
Barcelona
ZIP/Postal Code
08037
Country
Spain
Facility Name
Centro Nacional de Investigaciones Cardiovasculares Carlos III
City
Madrid
ZIP/Postal Code
28029
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34555181
Citation
Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
Results Reference
derived
PubMed Identifier
31277052
Citation
Fernandez-Jimenez R, Santos-Beneit G, Tresserra-Rimbau A, Bodega P, de Miguel M, de Cos-Gandoy A, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, Ibanez B, Storniolo C, Domenech M, Estruch R, Fernandez-Alvira JM, Lamuela-Raventos RM, Fuster V. Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial. Am Heart J. 2019 Sep;215:27-40. doi: 10.1016/j.ahj.2019.03.014. Epub 2019 Apr 10.
Results Reference
derived

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School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents

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